Sec. 10.10.06.13. Quality Control — Temporary and Mobile Laboratories: Personnel Training

A. Primary Standard. In addition to meeting other applicable requirements in this chapter, a licensee shall ensure that all laboratory personnel performing a health awareness test at a temporary or mobile laboratory are trained to perform all assigned duties.

B. Standards.

(1) All Personnel. A licensee shall ensure that all personnel are trained to:

(a) Keep examinees' health information confidential;

(b) Deal with emergency situations such as fainting and anxiety reactions;

(c) Report and document information on testing services and activities; and

(d) Dispose of special medical waste as set forth in COMAR 10.06.06.

(2) Phlebotomist. A licensee shall ensure that an individual who collects blood specimens is trained in:

(a) Specimen collection methods; and

(b) Infection control and prevention techniques, including CDC recommendations for preventing the transmission of bloodborne pathogens in health care settings.

(3) Operator of an Analytical System: General. A licensee shall ensure that an operator of an analytical system is trained in:

(a) Infection control and prevention techniques, including CDC recommendations concerning the transmission of bloodborne pathogens in health care settings; and

(b) Proper use of the analytical system, including:

(i) Analytical system operation;

(ii) System methods used to process the specimen; and

(iii) Quality control techniques, procedures, and requirements.

(4) Operator of an Analytical System: Competency.

(a) Obtaining Personal Competency. Before an individual may operate an analytical system without direct supervision, the individual operator shall demonstrate competency in operating the analytical system by completing:

(i) Pre-field supervised practice that includes performing under direct supervision a minimum of ten tests of each applicable type of health awareness test; and

(ii) Field testing experience that includes individual performance of directly supervised testing in the field.

(b) Documenting Training and Competency. The licensee shall document in writing that each analytical system operator has demonstrated competency as required under this regulation.